Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease

Official title

Study on the Efficacy and Safety of Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (tTIS) for Motor and Non-Motor Symptoms in Parkinson's Disease (PD): A Randomized, Double-Blind, Controlled Exploratory Trial

Overview

Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method. This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).

Detailed description

This is a single-center, randomized, double-blind, sham-controlled trial for Parkinson's disease (PD). The transcranial temporal interference stimulation (tTIS) intervention period is 5 days, with follow-up assessments conducted immediately after the intervention, 10 days post-intervention, and 30 days post-intervention. The real stimulation group receives bilateral subthalamic nucleus (STN) -targeted tTIS once daily for 5 days. Stimulation parameters: carrier frequencies of 2000/2130 Hz (Δf = 130 Hz), with stimulation lasting 20 minutes on each side. Before the intervention, T1-weighted structural images are acquired for each subject, and computational modeling based on an individual head model is performed to optimize electrode placement, individually focusing on the target side STN region. The sham group follows the same procedure but does not receive effective stimulation. The sham stimulation group receives only 30 seconds of fade-in/fade-out current at the beginning and end of the stimulation period to ensure blinding.

Interventions

• Device real transcranial temporal interference stimulation
  tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.
• Device sham transcranial temporal interference stimulation
  The sham stimulation is administered using the same procedure as the real tTIS.

Primary outcome measures

• Changes of motor function in PD [Time frame: Changes from baseline after 5 days of intervention (Day 5)]

Secondary outcome measures (11)

• Changes of motor function in PD [Time frame: Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])]
• Changes of Motor Complications in PD [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in cognition [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in anxiety [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in depression [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in sleep [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in daytime sleepiness [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in RBD [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in RLS [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in Non-Motor Aspects of Experiences of Daily Living [Time frame: Day 5, Day 15, Day 35]
• Assessment of changes in Motor Aspects of Experiences of Daily Living [Time frame: Time Frame: Day 5, Day 15, Day 35]

Eligibility criteria

Inclusion criteria

• Aged 50-85 years, male or female.
• Diagnosed with "clinically established" or "clinically probable" Parkinson's disease according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease.
• Hoehn-Yahr stage ≥ 2, and judged by the investigator to be able to cooperate in completing scale-based assessments and MRI examinations.
• Stable regimen of anti-Parkinsonian medication for at least 4 weeks before enrollment, and agreement to maintain a stable regimen during the main study phase unless medically necessary to change.
• Written informed consent signed by the study participant.

Exclusion criteria

• Non-primary Parkinson's disease or other parkinsonism / atypical parkinsonism.
• Previous receipt of invasive neuromodulation therapies such as deep brain stimulation (DBS) or other intracranial implantation/stereotactic brain surgery.
• Presence of contraindications or high-risk conditions for transcranial electrical stimulation (e.g., incompatible metal implants/implantable electrical stimulation devices, etc.), or judged by the investigator as unsuitable to receive transcranial electrical stimulation.
• Receipt of non-invasive neuromodulation interventions such as transcranial magnetic stimulation or transcranial electrical stimulation within the past six months.
• Presence of contraindications to MRI or inability to tolerate MRI examination.
• Significant cognitive impairment or severe psychiatric symptoms that prevent completion of assessments or result in poor compliance.
• New initiation or dose adjustment of medications or treatments that significantly affect sleep architecture/consciousness status within the past 4 weeks.
• History of epilepsy.
• Pregnancy or breastfeeding.
• Any other condition judged by the investigator as unsuitable for participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai General Hospital — Shanghai

Identifiers

NCT: NCT07625540 · Shanghai1st-2026-tTIS · No. 02.06.02.26.19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗